[Federal Register Volume 61, Number 129 (Wednesday, July 3, 1996)]
[Rules and Regulations]
[Pages 34741-34743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16857]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300419A; FRL-5381-2]
RIN 2070-AB78
Pentaerythritol Stearates; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This document establishes an exemption from the requirement of
a tolerance for residues of a mixture of chemicals known as
pentaerythritol stearates (CAS Reg. No. 85116-93-4), which include
pentaerythritol monostearate (CAS Reg. No. 78-23-9), pentaerythritol
distearate (CAS Reg. No. 13081-97-5), pentaerythritol tristearate (CAS
Reg. No. 28188-24-1), and pentaerythritol tetrastearate (CAS Reg. No.
115-83-3) when used as an inert ingredient (emulsifier) at a
concentration of no more than 25 ppm in pesticide formulations applied
to growing crops and to raw agricultural commodities after harvest.
This regulation was requested by Wacker Silicones Corporation, pursuant
to the Federal Food, Drug, and Cosmetic Act (FFDCA).
EFFECTIVE DATE: This regulation becomes effective July 3, 1996.
ADDRESSES: Written objections, identified by the docket number, [OPP-
300419A] may be submitted to: Hearing Clerk (1900), Environmental
Protection Agency, Rm. M3708, 401 M St., SW., Washington, DC 20460. A
copy of any objections and hearing requests filed with the Hearing
Clerk should be identified by the docket number and submitted to:
Public Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person, bring copy of
objections and hearing request to: Rm. 1132, CM#2, 1921 Jefferson Davis
Hwy., Arlington, VA 22202. Fees accompanying objections shall be
labeled ``Tolerance Petition Fees'' and forwarded to: EPA Headquarters
Accounting Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M,
Pittsburgh, PA 15251.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: [email protected].
Copies of objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption. Copies of objections and hearing requests will also be
accepted on disks in WordPerfect 5.1 file format or ASCII file format.
All copies of objections and hearing requests in electronic form must
be identified by the docket number (OPP-300419A). No ``Confidential
Business Information'' (CBI) should be submitted through e-mail.
Electronic comments on this proposed rule may be filed online at many
Federal Depository Libraries. Additional information on electronic
submissions can be found below in this document.
FOR FURTHER INFORMATION CONTACT: By mail: Amelia M. Acierto,
Registration Support Branch, Registration Division (7505W), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location and telephone number: Westfield
Building North, 6th Fl., 2800 Crystal Drive, Arlington, VA 22202, (703)
308-8375; e-mail: [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of April 17, 1996
(61 FR 16747), EPA issued a proposed rule (FRL-5355-7), gave notice
that Wacker Silicones Corporation, 3301 Sutton Road, Adrian, Michigan
49221-9397 had submitted pesticide petition (PP) 4E4378 to EPA
requesting that the Administrator, pursuant to section 408(e) of the
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e),
propose to amend 40 CFR 180.1001(c) by establishing an exemption from
the requirement of a tolerance for residues of a mixture of chemicals
known as pentaerythritol stearates (pentaerythritol monostearate (CAS
Reg. No. 78-23-9), pentaerythritol distearate (CAS Reg. No. 13081-97-
5), pentaerythritol tristearate (CAS Reg. No. 28188-24-1) and
pentaerythritol tetrastearate (CAS Reg. No. 115-83-3) when used as an
inert ingredient (emulsifier) in pesticide formulations applied to
growing crops or to raw agricultural commodities after harvest.
[[Page 34742]]
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125, and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
There were no comments or requests for referral to an advisory
committee received in response to the proposed rule.
The data submitted relevant to the proposal and other relevant
material have been evaluated and discussed in the proposed rule. Based
on the data and information considered, the Agency concludes that the
tolerance exemption will protect the public health. Therefore, the
tolerance exemption is established as set forth below.
Any person adversely affected by this regulation may, within 30
days after publication of this document in the Federal Register, file
written objections and/or request a hearing with the Hearing Clerk, at
the address given above (40 CFR 178.20). A copy of the objections and/
or hearing requests filed with the Hearing Clerk should be submitted to
the OPP docket for this rulemaking. The objections submitted must
specify the provisions of the regulation deemed objectionable and the
grounds for the objections (40 CFR 178.25). Each objection must be
accompanied by the fee prescribed by 40 CFR 180.33(i). If a hearing is
requested, the objections must include a statement of the factual
issue(s) on which a hearing is requested, the requestor's contentions
on such issues, and a summary of any evidence relied upon by the
objector (40 CFR 178.27). A request for a hearing will be granted if
the Administrator determines that the material submitted shows the
following: There is a genuine and substantial issue of fact; there is a
reasonable possibility that available evidence identified by the
requestor would, if established, resolve one or more of such issues in
favor of the requestor, taking into account uncontested claims or facts
to the contrary; and resolution of the factual issue(s) in the manner
sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32).
A record has been established for this rulemaking under docket
number (OPP-300419A) (including objections and hearing requests
submitted electronically as described below). A public version of this
record, including printed, paper versions of electronic comments, which
does not include any information claimed as CBI is available for public
inspection from 8 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The public record is located in Room 1132 of the Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments may be sent directly to EPA at:
[email protected].
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency
must determine whether the regulatory action is ``significant'' and
therefore subject to review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the order defines a ``significant regulatory action'' as an action that
is likely to result in a rule (1) having an annual effect on the
economy of $100 million or more, or adversely and materially affecting
a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local, or tribal
governments or communities (also referred to as ``economically
significant''); (2) creating serious inconsistency or otherwise
interfering with an action taken or planned by another agency; (3)
materially altering the budgetary impacts of entitlement, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; or (4) raising novel legal or policy issues arising out of
legal mandates, the President's priorities, or the principles set forth
in this Executive Order. Pursuant to the terms of the Executive Order,
EPA has determined that this rule is not ``significant'' and is
therefore not subject to OMB review.
This action does not impose any enforceable duty, or contain any
``unfunded mandates'' as described in Title II of the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as
specified by Executive Order 12875 (58 FR 58093, October 28, 1993),
entitled Enhancing the Intergovernmental Partnership, or special
consideration as required by Executive Order 12898 (59 FR 7629,
February 16, 1994).
Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted
a report containing this rule and other required information to the
U.S. Senate, the U.S. House of Representatives and the Comptroller
General of the General Accounting Office prior to publication of the
rule in today's Federal Register. This rule is not a ``major rule'' as
defined by 5 U.S.C. 804(2) of the APA as amended.
Pursuant to the requirements of the Regulatory Flexibility Act
(Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator
has determined that regulations establishing new tolerances or raising
tolerance levels or establishing exemptions from tolerance requirements
do not have a significant economic impact on a substantial number of
small entities. A certification statement to this effect was published
in the Federal Register of May 4, 1981 (46 FR 24950).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 24, 1996.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
[[Page 34743]]
2. The table in Sec. 180.1001(c) is amended by adding
alphabetically the inert ingredient, to read as follows:
Sec. 180.1001 Exemptions from the requirement of a tolerance.
* * * * *
(c) * * *
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Inert ingredients Limits Uses
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* * * * * * *
Pentaerythritol stearates No more than 25 Emulsifier
mixture (CAS Reg. No. 85116- ppm in
93-4) which include pesticide
pentaerythritol monostearate formulations.
(CAS Reg. No. 78-23-9),
pentaerythritol distearate
(CAS Reg. No. 13081-97-5),
pentaerythritol tristearate
(CAS Reg. No. 28188-24-1)
and pentaerythritol
tetrastearate (CAS Reg. No.
115-83-3).
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[FR Doc. 96-16857 Filed 7-2-96; 8:45 am]
BILLING CODE 6560-50-F